Global Regulatory Issues in Gene Therapy Development

Monday, November 4 | 9 a.m.–5 p.m.


The goal of this program is to explore solutions to challenges experienced both by global regulators and by sponsors developing gene therapies across established and emerging markets. Scheduled topics include identifying differences in regulatory requirements and areas of opportunity for greater convergence of regulatory frameworks.

Objectives:

  1. To inform attendees about differences in regulatory requirements in established and emerging markets
  2. To discuss the challenges of global development and to engage in dialogue about areas of opportunity for harmonization to support development of gene therapy
  3. To shape recommendations on potential movement toward convergence of regulatory frameworks

Full Agenda

Meeting Welcome & Introduction

  • Adora Ndu, PharmD, J.D.
    BioMarin

Developments in Gene Therapy Policy Landscape

  • Renata Miranda Parca
    Office of Blood, Cells, Tissues and Organs, Brazilian Health Regulatory Agency (ANVISA)
  • Keith Wonnacott, Ph.D.
    Pfizer, Inc.
  • John C. Bolzano
    Covington & Burling, LLP

Moderated Panel:

  • Moderator: Keith Wonnacott, Ph.D.
    Pfizer, Inc.
  • Martin Hernan Bonamino, Ph.D.
    National Cancer Institute, member of ANVISA’s Advanced Therapy Technical Committee

The Relevance of Global Regulatory Convergence to Accelerating the Availability of Gene Therapies

Keynote Speaker: Peter Marks, M.D., Ph.D.
Director of FDA CBER

Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research (FDA CBER), opens the first day of the 2019 Policy Summit with potential areas for increased convergence of global regulatory policies for gene therapies, and the significance of striving toward this goal, as part of a session on the challenges and opportunities for developing multinational programs.

Identification of Challenges and Opportunities for Multinational Gene Therapy Programs

Regulators from Europe, Japan, and the United States will provide updates and discuss difficulties and opportunities in enabling sustainable and adaptable regulatory frameworks for gene therapies:

  • Rune Kjeken, Ph.D.
    Scientific Director, Advanced Therapies, Norwegian Medicines Agency
  • Kimberly Schultz, Ph.D.
    Gene Therapy Product Reviewer, Division of Cellular and Gene Therapies, FDA CBER
  • Megumu Mori, M.D., Ph.D.
    Medical Device Evaluation Division, Ministry of Health, Labour and Welfare, Japan
  • Industry presentation: Experience and challenges faced in global development and opportunities for harmonization

Moderated Panel:

  • Moderator: Maritza McIntyre, Ph.D.
    President, Advanced Therapies Partners, LLC
  • Kimberly Schultz, Ph.D.
    Gene Therapy Product Reviewer, Division of Cellular and Gene Therapies, FDA CBER
  • Rune Kjeken, Ph.D.
    Scientific Director, Advanced Therapies, Norwegian Medicines Agency
  • Megumu Mori, M.D., Ph.D.
    Medical Device Evaluation Division, Ministry of Health, Labour and Welfare, Japan

Rates:

  • Member: $200
  • Non-Member: $250

Register Online for the
ASGCT Policy Summit

Register today for the Monday, Novemeber 4 session, Global Regulatory Issues in Gene Therapy Development, or all of the ASGCT 2019 Policy Summit (a PDF registration form is also available).

Cancellation Policy: Refund requests must be submitted in writing to ASGCT prior to October 21, 2019. A $35 processing fee will be charged for all refunds. We regret refunds cannot be allowed for requests postmarked or received after October 21, 2019.

Special Accommodations: If you require special accommodations under the ADA in order to fully participate in the meeting, please send a written description of your needs to the ASGCT Executive Office. Please notify us of your needs by October 28, 2019.

2019
ASGCT Policy Summit
November 4 – 6 | Washington D.C.
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